Long-Term Outcomes Following Withdrawal of Anti-Tumour Necrosis Factor Treatment in Inflammatory Bowel Disease Patients in Remission: The Exit Long-Term Study of GETECCU.

BACKGROUND

The EXIT trial found no difference in sustained remission at 12 months between inflammatory bowel disease (IBD) patients in remission who withdrew anti-TNF therapy [withdrawal arm (WA)] and those who maintained treatment [maintenance arm (MA)].

AIMS: To compare the long-term risk of relapse between these groups and assess the response to anti-TNF resumption.

METHODS

This was a follow-up extension of the EXIT trial. We analysed long-term outcomes of patients in sustained clinical remission from the start of EXIT.

RESULTS

We included 125 patients (63 in MA and 62 in WA). Median follow-up was 12 months for MA and 26 months for WA. The cumulative incidence of relapse (95% CI) was 35% (23%-48%) in MA and 47% (34%-60%) in WA; p = 0.3. In MA, relapses occurred in 8% of patients by 12 months and 47% by 24 months. In WA, relapses occurred in 16% by 12 months and 39% by 24 months. The incidence rate of relapse per patient-year was 22% in MA and 19% in WA. Baseline faecal calprotectin > 250 μg/g was the only variable associated with a higher risk of relapse. Of the 29 patients who relapsed in WA, 26 (90%) resumed anti-TNF therapy; of these, 69% regained clinical remission.

CONCLUSION

In this extended analysis of patients included in the EXIT trial, withdrawing anti-TNF therapy in patients with IBD in remission was not associated with a higher long-term relapse risk.